Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals With Alcohol Use Disorder

N/AActive Not RecruitingNCT05787106

Centre Hospitalier Universitaire de Nīmes58 enrolled

Overview

Low utilization of addiction treatment is a public health problem. A number of factors are associated with lack of treatment, including public stigma, self-stigma, and beliefs that people with addiction should solve their problem on their own. Stigma exposes individuals to social rejection, which may sustain the anxiety of rejection, and exacerbate certain mental disorders such as addictions. Social cognition disorders have been shown to be present in addictions, but one dimension of social cognition, emotional sensitivity to rejection (ESR), has been less studied. Rejection sensitivity could be considered a critical element in access to care and the relapse process. The study authors hypothesize a role for emotional dysregulation in rejection situations in the relapse of alcohol use disorder in recently withdrawn patients. Specifically, they hypothesize that participants with a greater change in negative experience after a rejection situation on a Cyberball task, as measured by the negative subscale of the Positive and Negative Affect Schedule (PANAS), will have a higher percentage of days with heavy drinking during the last four weeks to three months of follow-up.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Alcohol-Induced Disorders Ostracism

Interventions

Cyberball taskOTHER

The game consists of ball throws between animated characters lasting about 50 throws. In the rejection condition, after 2 or 3 throws, the participant no longer receives the ball (no more passes). In the control conditions ("all included"), the participant receives the ball as often as the others.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient admitted to the Grau-du-Roi Follow-up and Rehabilitation Care Service. * Patient abstinent from alcohol for at least 10 days. * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan Exclusion Criteria: * Other mental health disorder: bipolar disorder, schizophrenia, severe acute depression, borderline personality. * Severe substance use disorder (SUD). * Current suicidal ideation as judged by clinician. * Patient unable to give consent. * Pregnant or breastfeeding patient. * The subject is participating in a Category 1 interventional study, or is in a period of exclusion determined by a previous study * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship

Locations (1)

CHU de Nîmes

Nîmes, Nîmes, France

Outcomes

Primary Outcomes

Role of emotional reaction to social rejection (Cyberball game)

Positive And Negative Affect Schedule (PANAS) (negative affect score). Scores can range from 10 to 50 for positive and negative emotions, with lower scores representing lower levels of positive/negative emotional engagement and higher scores representing higher levels of positive/negative emotional engagement.

Time frame: Day 0; before Cyberball task

Role of emotional reaction to social rejection (Cyberball game)

Time frame: Day 0; after Cyberball task

Percentage of heavy drinking days in the past 4 weeks

Timeline Follow Back (TLFB) interview

Time frame: Month 3

Correlation between percentage of heavy drinking days and the difference between the PANAS negative subscale scores at baseline and after the Cyberball task in the exclusion phase (=rejection situation).

Multiple linear regression

Time frame: Day 0; before Cyberball task

Multiple linear regression

Time frame: Day 0; after Cyberball task

Multiple linear regression

Time frame: Month 3

Secondary Outcomes

Adverse childhood events

Adverse childhood events (ACE) score

Time frame: Day 0

Patient level of distress due to rejection

Need Threat Scale (NTS) score

Time frame: Day 0; after Cyberball task

Patient self-stigma due to alcohol dependence

Self-stigma in Alcohol Dependence (SSAD) scale score

Time frame: Day 0

Patient depression

Patient Health Questionnaire (PHQ-9) score

Time frame: Day 0

Patient depression

Patient Health Questionnaire (PHQ-9) score

Time frame: Month 3

Patient depression

Patient Health Questionnaire (PHQ-9) score

Time frame: Month 6

Patient depression

Patient Health Questionnaire (PHQ-9) score

Time frame: Month 12

Patient anxiety

Generalized Anxiety Disorder-7 (GAD-7) score

Time frame: Day 0

Patient anxiety

Generalized Anxiety Disorder-7 (GAD-7) score

Time frame: Month 3

Patient anxiety

Generalized Anxiety Disorder-7 (GAD-7) score

Time frame: Month 6

Patient anxiety

Data from ClinicalTrials.gov

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Generalized Anxiety Disorder-7 (GAD-7) score

Time frame: Month 12

Number of days of alcohol consumption in the past 4 weeks

Timeline Follow Back (TLFB) interview

Time frame: Month 3

Number of days of alcohol consumption in the past 4 weeks

Timeline Follow Back (TLFB) interview

Time frame: Month 6

Number of days of alcohol consumption in the past 4 weeks

Timeline Follow Back (TLFB) interview

Time frame: Month 12

Number of days of heavy alcohol consumption in the past 4 weeks

Timeline Follow Back (TLFB) interview

Time frame: Month 3

Number of days of heavy alcohol consumption in the past 4 weeks

Timeline Follow Back (TLFB) interview

Time frame: Month 6

Number of days of heavy alcohol consumption in the past 4 weeks

Timeline Follow Back (TLFB) interview

Time frame: Month 12

Percentage of heavy drinking days in the past 4 weeks

Timeline Follow Back (TLFB) interview

Time frame: Month 3

Percentage of heavy drinking days in the past 4 weeks

Timeline Follow Back (TLFB) interview

Time frame: Month 6

Percentage of heavy drinking days in the past 4 weeks

Timeline Follow Back (TLFB) interview

Time frame: Month 12

Lifetime history of suicide attempts

Number

Time frame: Day 0

Current treatments

List of current treatments taken from patient medical file

Time frame: Day 0

Patient dispositional (i.e. trait) empathy

Interpersonal reactivity index (IRI) score

Time frame: Day 0

Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Positive And Negative Affect Schedule (PANAS) after the rejection situation.

Time frame: Day 0; before Cyberball task

Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Positive And Negative Affect Schedule (PANAS) after the rejection situation.

Time frame: Day 0; after Cyberball task

Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Need Threat Scale (NTS) after the rejection situation.

Time frame: Day 0; before Cyberball task

Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Need Threat Scale (NTS) after the rejection situation.

Time frame: Day 0; after Cyberball task